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An Observational Study to Assess Malnutrition Risk

CROSS: Colombia's Potential Realized: an Observational Study for Stunting

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06709001
Enrollment
206
Registered
2024-11-29
Start date
2024-12-09
Completion date
2025-07-25
Last updated
2025-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malnutrition

Brief summary

This is a prospective, observational study for assessing malnutrition risk and its characteristics among children aged 1 to 5 living in under-resourced communities in Colombia. There is also a qualitative component that seeks to gain caregiver, community health worker (CHW), public health professional (PHP), and non-for-profit organization (NGO) insights related to malnutrition risk.

Interventions

None listed

Sponsors

Children International
CollaboratorUNKNOWN
Abbott Nutrition
Lead SponsorINDUSTRY

Study design

Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Years to 5 Years
Healthy volunteers
No

Inclusion criteria

Quantitative Inclusion Criteria: * Children aged 1-5 years * Children's legal guardian agrees to participate in the study * Full term pregnancy * Residence in study area attending Children International (NGO) centers Quantitative

Exclusion criteria

* Children who have current medical conditions requiring hospitalization: gastrointestinal tract infections or inflammatory bowel disease; active tuberculosis; acute hepatitis B or C; human immunodeficiency virus OR malignancy; cystic fibrosis; immunodeficiency syndromes, congenital abnormalities of the respiratory tract, such as lung and respiratory cilia; an unsuspected foreign body in the respiratory tract; asthma; and known metabolic disorders, renal impairment, or rheumatic diseases and diabetes, * Congenital condition * Children with disabilities such as cerebral palsy, autism spectrum disorder, neurodegenerative disorders * Children with chronic or acute infections e.g. HIV, malaria * Children who are taking medications or other agents that could potentially affect body weight, including diuretics, appetite stimulants, steroids, and growth hormones. * Children already enrolled in a nutrition program/intervention that includes a supplement Qualitative Inclusion Criteria: * NGO staff taking part in nutrition screenings * Caregivers taking part in nutrition screenings as part of this study * Community health workers (CHW) working with pediatric malnutrition risk * Public health professionals (PHP) working with pediatric malnutrition risk * Agrees to participate in focus group/survey Qualitative

Design outcomes

Primary

MeasureTime frameDescription
Anthropometrics - Mid-Upper Arm Circumference (MUAC)Baseline, 3 Months and 6 MonthsMeasured in mm
Anthropometrics - Height/LengthBaseline, 3 Months and 6 MonthsMeasured in cm

Secondary

MeasureTime frameDescription
Anthropometrics - Head CircumferenceBaseline, 3 Months and 6 MonthsMeasured in cm
Nutrient IntakeBaseline and 6 MonthsCaregiver completed 24-hour dietary recall
Anthropometrics - WeightBaseline, 3 Months and 6 MonthsMeasured in kg
Pediatric Quality of Life InventoryBaseline and 6 MonthsA 23-item questionnaire rated 0 to 4 where higher scores indicate better health-related quality of life
World Health Organization Quality of Life Brief VersionBaseline and 6 Monthsa 26-item caregiver completed questionnaire scored 0 to 100 where higher scores indicate higher quality of life
Healthcare Resource UtilizationBaseline and 6 MonthsCaregiver completed questionnaire to obtain illness frequency, severity and related missed school/work days. Higher frequency, severity and missed days associated with greater healthcare utilization.

Other

MeasureTime frameDescription
Focus Groups with NGOs, Caregivers, CHWs, PHPsBaseline, 3 Months and 6 MonthsNutrition program feasibility discussion related to nutrition screening and program participation
Staff Insights Questionnaire6 MonthsA non-statistical 6-item questionnaire completed by the NGO Staff to obtain feedback on their experience with nutrition screening
Process OutcomesBaseline, 3 Months and 6 MonthsEnrollment and adherence to nutrition program

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026